Medical Device Regulation (EU) 2017/745 (MDR)

I support Legal Manufacturers, Importers and Distributors to ensure compliance with Medical Device Regulation (MDR).

The tasks are typically:

  • Introduction and overview of requirements in Medical Device Regulation (MDR)
  • Detailed analysis of requirements for the specific company and/or products
  • Gap analysis between existing set-up and MDR including proposal for implementation
  • Classification of products
  • Implementation of UDI and Basic UDI
  • Readiness for reporting to EUDAMED
  • Implementation / optimization of quality management system in compliance with ISO 13485
  • Implementation / optimization of  quality management system for importers and distributors


Link to Medical Device Regulation